- |||||||||| Clinical, Review, Journal: Direct-Acting Antivirals interactions with opioids, alcohol or illicit drugs in HCV-infected patients. (Pubmed Central) - Mar 24, 2021
Based on pharmacological considerations, neither efficacy loss, nor adverse drug event associated with detrimental interaction are expected with opioids, stimulants, cannabinoids, and ethanol. In summary, our literature review shows that the interaction potential of DAA with most opioids and illicit drugs is limited and should not be a hurdle to the initiate DAA.
- |||||||||| Daklinza (daclatasvir) / BMS
[VIRTUAL] ADEQUATE DACLATASVIR EXPOSURES IN CHILDREN 14-35 KG WITH AVAILABLE ADULT FORMULATIONS () - Mar 18, 2021 - Abstract #CROI2021CROI_653;
DCV 30 mg OD is expected to provide exposures comparable to adult values in children 14-35 kg. Our results suggest that children could be treated using currently available low-cost DCV formulations together with approved doses of pediatric SOF formulations, thus expanding access to HCV treatment.
- |||||||||| Journal: Raltegravir, Indinavir, Tipranavir, Dolutegravir, and Etravirine against main protease and RNA-dependent RNA polymerase of SARS-CoV-2: A molecular docking and drug repurposing approach. (Pubmed Central) - Dec 18, 2020
The ZnS NPs/ rGO modified GCE was used to quantify HCQ and DAC in biological fluids with recoveries of 98.7-102.7% and 96.9-104.5% and RSDs of 1.89-3.57% and 1.91-3.70%, respectively. This study suggests that the screened small molecule antiviral drugs Raltegravir, Indinavir, Tipranavir, Dolutegravir, and Etravirine could serve as potential drugs for the treatment of COVID-19 with further validation studies.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Trial completion date, Trial primary completion date: Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients (clinicaltrials.gov) - Dec 3, 2020
P2/3, N=100, Recruiting,
Collectively, we suggest that drugs predicted to have strong inhibitory potencies to ACE2 and TMPRSS2 through the DTI model should be considered as potential drug repurposing candidates for COVID-19. Trial completion date: Oct 2020 --> Apr 2021 | Trial primary completion date: Oct 2020 --> Apr 2021
- |||||||||| Daklinza (daclatasvir) / BMS
[VIRTUAL] HAEMOPHILIA A PATIENT WITH COMPLETE ATRIOVENTRICULAR BLOCK: CASE REPORT () - Nov 26, 2020 - Abstract #HEMO2020HEMO_110;
He had gout (allopurinol) and arterial hypertension (indapamide, losartan and clonidine)...Hepatitis C virus was treated with daclatasvir with sofosbuvir...Till now, only a few cases of pacemaker insertion in people with haemophilia have been described. It is a minor procedure and a multidisciplinary approach can ensure its success with minimal bleeding risk.
- |||||||||| Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Trial completion date, Trial primary completion date: REVOLUTIOn: Antiviral Agents Against COVID-19 Infection (clinicaltrials.gov) - Nov 9, 2020
P2/3, N=1005, Not yet recruiting,
This may provide a potential simple strategy for CHC treatment without GT determination. Trial completion date: Dec 2021 --> Apr 2021 | Trial primary completion date: Dec 2021 --> Feb 2021
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Unusual complexation behavior between daclatasvir and γ-Cyclodextrin. A multiplatform study. (Pubmed Central) - Oct 21, 2020
The RSSR-diastereomer of DCV as well as an analog lacking one of the amino acid moieties also formed 1:1 and 2:1 complexes with γ-CD although a plateau was only observed in the case of the RSSR-diastereomer. As shown by CE-MS, both DCV-γ-CD complexes surprisingly comigrated as the first peak, while the second migrating peak represents non-complexed DCV.
- |||||||||| Olysio (simeprevir) / J&J, Medivir, Daklinza (daclatasvir) / BMS
Journal: Validated Reversed-Phase Liquid Chromatographic Method with Gradient Elution for Simultaneous Determination of the Antiviral Agents: Sofosbuvir, Ledipasvir, Daclatasvir, and Simeprevir in Their Dosage Forms. (Pubmed Central) - Oct 21, 2020
The analytical performance of the newly proposed HPLC procedure was thoroughly validated according to ICH guidelines in terms of linearity, precision (RSD%, 0.39-1.57), accuracy (98.05-101.90%), specificity, limit of detection (LOD) (0.022-0.039 μg/mL), limit of quantification (LOQ) (0.067-0.118 μg/mL), and robustness. The validated HPLC method was successfully used to analyze the abovementioned drugs in their pure and dosage forms without interference from common excipients present in commercial formulations.
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Repurposing Hepatitis C Direct -acting antivirals against COVID-19. (Pubmed Central) - Oct 20, 2020
The validated HPLC method was successfully used to analyze the abovementioned drugs in their pure and dosage forms without interference from common excipients present in commercial formulations. No abstract available
- |||||||||| Daklinza (daclatasvir) / BMS, Sovodak (daclatasvir/sofosbuvir) / Rojan Pharma
Clinical, Journal: Efficacy of Sovodak in the Management of Patients Co-infected with HIV/HCV. (Pubmed Central) - Oct 20, 2020
For the first time, the results of the present study showed that Sovodak had high SVR12 in HCV patients co-infected with HIV. However, for a precise conclusion, there is a need for larger studies and an equal number of patients with different virus genotypes.
- |||||||||| Copegus (ribavirin) / Bausch Health, Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Real life Egyptian experience of Daclatasvir plus Sofosbuvir with Ribavirin in naïve difficult to treat HCV patients. (Pubmed Central) - Oct 11, 2020
The available evidence seems to suggest that combination therapy of (DCV/SOF with RBV) in the treatment of chronic HCV genotype IV naïve difficult to treat patients either cirrhotic or non-cirrhotic is safe and effective. Monitoring for clinical and laboratory hepatic parameters was the basis for these findings.
- |||||||||| Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
[VIRTUAL] GENETIC ANALYSIS OF DAA RESISTANT HCV BY SINGLE-MOLECULE, LONG-READ SEQUENCING USING NANOPORE SEQUENCER () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1002;
In the treatment of DAA, it was suggested that the combination of various mutations other than the known signature RAS influences the kinetics of individual HCV quasispecies in response to the treatment. Dynamic analysis of HCV haplotype by the present method will provide novel information about the role of HCV diversities within the host, which is useful for elucidation of the pathological mechanism and control of HCV related diseases.
- |||||||||| Ledipasvir (GS-5885) / Gilead, Daklinza (daclatasvir) / BMS
[VIRTUAL] EFFICACY, TOLERABILITY AND COMPLIANCE OF DIRECTLY ACTING ANTIVIRALS IN PATIENTS WITH HEPATITIS C AND HIV CO-INFECTION: REAL LIFE EXPERIENCE FROM A TERTIARY CARE CENTER IN INDIA () - Oct 11, 2020 - Abstract #AASLD2020AASLD_908;
Dose modifications of DAAs (Daclatasvir and Ledipasvir) were done depending on interactions with concurrent ART regimen...ART regimen comprised of a combination of Tenofovir(T), Lamivudine(L), Efavirenz (E), Nevirapine (N), and/or Zidovudine (Z) at standard dosage and modifications as applicable to individual patients [TLE: 63(82.9%), ZLN:11(14.5%) and ZLE: 2(2.6%)]... HCV-HIV coinfected patients demonstrate excellent SVR12 rates and tolerability with available DAAs; however, dismal proportion of these patients seek and complete their treatment, outlining the need of better counselling, screening and outreach programs among this high-risk group of patients.
- |||||||||| [VIRTUAL] Choice of Recommended Treatment Options for Patients with Hepatitis C Genotype 1 in Moscow, Russian Federation () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1904;
In genotype 1b patients independent of subgroups top-4 regimens were: daclatasvir+sofosbuvir±ribavirin (€ 5938), grasoprevir+elbasvir (€ 5964), dasabuvir+ombitasvir+paritaprevir+ritonavir (€ 6219) and velpatasvir+sofosbuvir (€6223). As a result of a transparent and scientific-based analysis were selected treatment regimens for patients with chronic HCV genotype 1 recommended for reimbursement in Moscow in 2020.
- |||||||||| [VIRTUAL] Choice of Recommended Treatment Options for Patients with Hepatitis C Genotypes 2 and 3 in Moscow, Russian Federation () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_957;
Based on the results of the analysis, several recommended schemes were selected for each of the target sub-groups (due to the fact that the cost of the course of treatment and the efficacy of all top regimens were comparable): In genotype 2 patients independent of subgroups top-3 regimens were: sofosbuvir+ribavirin (€ 3901 per course), daclatasvir+sofosbuvir±ribavirin (€ 5938 per course), velpatasvir+sofosbuvir (€ 6223 per course). As a result of scientific-based analysis were selected treatment regimens for patients with chronic HCV genotypes 2 and 3 recommended for reimbursement in Moscow in 2020.
- |||||||||| paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS
Clinical, Journal, Real-World Evidence: Direct antiviral therapy for treatment of hepatitis C: A real-world study from Brazil. (Pubmed Central) - Sep 30, 2020
In patients with chronic hepatitis C genotype 3, SOF/RBV and SOF/DCV±RBV have similar sustained viral response, and patients with liver cirrhosis and past treatment experience have suboptimal response in Pakistan. SOF-based DAA regimens are effective and safe in the heterogeneous highly admixed Brazilian population and could remain an option for HCV treatment at least in low-income countries.
- |||||||||| Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Journal: Sofosbuvir inhibits yellow fever virus in vitro and in patients with acute liver failure. (Pubmed Central) - Sep 30, 2020
Sofosbuvir may be used as an option for treatment against YFV until other drugs are identified and approved for human use. These results offer insights into the role of nonstructural protein 5 (NS5) in YFV inhibition and suggest that nonstructural proteins may be explored as drug targets for YFV treatment.
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: GSK2818713, a novel biphenylene scaffold-based Hepatitis C NS5A replication complex inhibitor with broad genotype coverage. (Pubmed Central) - Sep 26, 2020
The discovery of GSK2818713 (13), a nonstructural protein 5A (NS5A) HCV inhibitor characterized by a significantly improved genotype coverage relative to first-generation NS5A inhibitor daclatasvir (DCV), is detailed herein...Long term treatment of subgenomic replicons with 13 potently and durably decreased HCV RNA levels for genotype 1a (gt1a), gt2a and gt3a. These properties, as well as the lack of cross-resistance, of antagonism with other HCV agents and suitable pharmacokinetic properties, identified 13 as a preclinical candidate.
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Direct Antiviral Treatments for Hepatitis C Virus Have Off-Target Effects of Oncologic Relevance in Hepatocellular Carcinoma. (Pubmed Central) - Sep 25, 2020
These properties, as well as the lack of cross-resistance, of antagonism with other HCV agents and suitable pharmacokinetic properties, identified 13 as a preclinical candidate. Our findings suggested the possible occurrence of off-target effects ultimately modulating cell proliferation and/or migration and potentially justified previous findings showing some instances of particularly aggressive HCC recurrence as well as reduced incidence of recurrence of HCC following treatment with DAAs.
- |||||||||| Copegus (ribavirin) / Bausch Health, Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Journal: Daclatasvir plus sofosbuvir, with or without ribavirin, is highly effective for all kinds of genotype-2 chronic hepatitis-C infection in Taiwan. (Pubmed Central) - Sep 24, 2020
Our findings suggested the possible occurrence of off-target effects ultimately modulating cell proliferation and/or migration and potentially justified previous findings showing some instances of particularly aggressive HCC recurrence as well as reduced incidence of recurrence of HCC following treatment with DAAs. Our real-world cohort of Taiwan showed that a 12-week SOF/DCV-based treatment was well-tolerated and highly effective for genotype-2 CHC patients with or without liver cirrhosis.
- |||||||||| Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Enrollment change: REVOLUTIOn: Antiviral Agents Against COVID-19 Infection (clinicaltrials.gov) - Sep 19, 2020
P2/3, N=1134, Not yet recruiting,
Using these approaches together with the MIRM-ISCC methodology, accurate and reliable LC-MS/MS bioanalysis can be achieved without the need of preparation of multi-sample external calibration curve and dilution of study samples. N=189 --> 1134
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Enrollment change, Trial completion date, Trial primary completion date: Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients (clinicaltrials.gov) - Sep 14, 2020
P2/3, N=100, Recruiting,
The use of this pathway could be a key part of an integrated and effective approach to HCV elimination at a community level. N=200 --> 100 | Trial completion date: Dec 2030 --> Oct 2020 | Trial primary completion date: Dec 2030 --> Oct 2020
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Hepatitis C virus treatment in people who inject drugs (PWID) in Bangladesh. (Pubmed Central) - Sep 5, 2020
N=200 --> 100 | Trial completion date: Dec 2030 --> Oct 2020 | Trial primary completion date: Dec 2030 --> Oct 2020 Our findings strongly suggest that HCV treatment using sofosbuvir+daclatasvir for PWID enrolled in existing harm reduction programs in Bangladesh is feasible but may require additional interventions such as Opioid Substitution Therapy, intense follow up by outreach workers, and services and counselling provided by full time clinicians.
- |||||||||| pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, Daklinza (daclatasvir) / BMS
PK/PD data, Review, Journal: Viral Hepatitis C Therapy: Pharmacokinetic and Pharmacodynamic Considerations: A 2019 Update. (Pubmed Central) - Sep 5, 2020
We briefly discuss the relationship between the pharmacokinetics of the DAAs and efficacy or toxicity in special populations, such as hard to cure patients and patients with liver cirrhosis, liver transplantation, renal impairment, hepatitis B virus or HIV co-infection, bleeding disorders, and children. The aim of this overview is to educate/update prescribers and pharmacists so that they are able to safely and effectively treat HCV-infected patients even in the presence of underlying co-infections or co-morbidities.
- |||||||||| Daklinza (daclatasvir) / BMS
Clinical, Retrospective data, Journal: Effectiveness of direct-acting antivirals for hepatitis C virus infection in hepatitis C/HIV coinfected individuals: A multicenter study. (Pubmed Central) - Aug 27, 2020
In a hepatitis C virus (HCV)/HIV-positive Brazilian cohort, evaluate the safety and efficacy of HCV DAAs, the frequency of resistance substitutions in the HCV NS5A and NS5B genes and identify predictors of treatment failure.Retrospective multicenter study of HCV/HIV patients treated with sofosbuvir (SOF)-based regimens at 10 reference centers in Brazil.Clinical and virological data were collected...An SOF/daclatasvir (DCV) regimen was used in most patients (98%)...By multivariate analysis, therapeutic failure was associated, in the m-ITT analysis, with concomitant use of anticonvulsant drugs (P = .001), age (P = .04), and female gender (P = .04).SOF/DCV regimens were associated with a high SVR rate in an HCV/HIV population. The use of concurrent anticonvulsant drugs and DAAs decreases the chances of achieving an SVR.
- |||||||||| FDA event, Journal: Structure-based virtual screening of phytochemicals and repurposing of FDA approved antiviral drugs unravels lead molecules as potential inhibitors of coronavirus 3C-like protease enzyme. (Pubmed Central) - Aug 26, 2020
Among the phytochemicals, 11,646,359 (Vincapusine), 120,716 (Alloyohimbine) and 10,308,017 (Gummadiol) showed triple inhibition potential against all the three targets and 102,004,710 (18-Hydroxy-3-epi-alpha-yohimbine) exhibited dual inhibition potential. Hence, the proposed lead molecules from our findings can be further investigated through in vitro and in vivo studies to develop into potential drug candidates against human coronaviral infections.
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